The Importance of Complementary Feeding on Growth, Nutritional Status and Markers for Disease. An Intervention Study With Milk Types and LC-PUFA Supplements in 9- to 12-Month-Old Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Growth
研究概览
简要总结
The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 8 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton infants
- •Born >= 37 wk of gestation
- •Birth weight > 2500g
- •>= 5th percentile for gestational age
- •A 5-min Apgar score >= 7
- •Daily consumption of cow's milk or formula
排除标准
- •No major complications at birth or in fetal life
- •No chronic diseases
结局指标
主要结局
Growth
Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
IGF-I
IGFBP-3
Insulin - glucose metabolism (HOMA index).
Urea Nitrogen
Albumin
C-peptide
Amino Acids
Erythrocyte fatty acid composition
Blood pressure
Lipid Profile
Heart Rate Variability (HRV)
In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
Plasma IgE, IL-2R, and CRP
次要结局
- Plasma concentrations of cholesterol and triglycerides
- Allergy status
- Cognitive test ("The infant means-end problem solving test")
- Iron status (hemoglobin, ferritin and transferrin receptors)
- Feces samples: Calprotectin, IgA and composition of the intestinal microbiota